PlainRecalls
FDA Drug Moderate Class II Terminated

Tacrolimus Capsules, USP 1mg, 100-Count Bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally, 500 090, INDIA, NDC 55111-526-01

Reported: January 17, 2024 Initiated: December 15, 2023 #D-0219-2024

Product Description

Tacrolimus Capsules, USP 1mg, 100-Count Bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally, 500 090, INDIA, NDC 55111-526-01

Reason for Recall

Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.

Details

Units Affected
8,280 bottles
Distribution
US Nationwide.
Location
Princeton, NJ

Frequently Asked Questions

What product was recalled?
Tacrolimus Capsules, USP 1mg, 100-Count Bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally, 500 090, INDIA, NDC 55111-526-01. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 8,280 bottles.
Why was this product recalled?
Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 17, 2024. Severity: Moderate. Recall number: D-0219-2024.